Beyaz

INDICATIONS

Oral Contraceptive

Beyaz™ is indicated for use by women to prevent pregnancy.

Premenstrual Dysphoric Disorder (PMDD)

Beyaz is also indicated for the treatment of symptoms of
premenstrual dysphoric disorder (PMDD) in women who choose to use an oral
contraceptive as their method of contraception. The effectiveness of Beyaz for
PMDD when used for more than three menstrual cycles has not been evaluated.

The essential features of PMDD according to the Diagnostic
and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood,
anxiety or tension, affective lability, and persistent anger or irritability.
Other features include decreased interest in usual activities, difficulty
concentrating, lack of energy, change in appetite or sleep, and feeling out of
control. Physical symptoms associated with PMDD include breast tenderness,
headache, joint and muscle pain, bloating and weight gain. In this disorder,
these symptoms occur regularly during the luteal phase and remit within a few
days following onset of menses; the disturbance markedly interferes with work
or school, or with usual social activities and relationships with others.
Diagnosis is made by healthcare providers according to DSM-IV criteria, with
symptomatology assessed prospectively over at least two menstrual cycles. In
making the diagnosis, care should be taken to rule out other cyclical mood
disorders.

Acne

Beyaz is indicated for the treatment of moderate acne
vulgaris in women at least 14 years of age, who have no known contraindications
to oral contraceptive therapy and have achieved menarche. Beyaz should be used
for the treatment of acne only if the patient desires an oral contraceptive for
birth control.

Folate Supplementation

Beyaz is indicated in women who choose to use an oral
contraceptive as their method of contraception, to raise folate levels for the
purpose of reducing the risk of a neural tube defect in a pregnancy conceived
while taking the product or shortly after discontinuing the product.

DOSAGE AND ADMINISTRATION

How to Take Beyaz

Take one tablet by mouth at the same time every day. The
failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive and PMDD effectiveness,
Beyaz must be taken as directed, in the order directed on the blister pack.
Single missed pills should be taken as soon as remembered.

How to Start Beyaz

Instruct the patient to begin taking Beyaz either on the
first day of her menstrual period (Day 1 Start) or on the first Sunday after
the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of Beyaz use, instruct the patient to
take one pink Beyaz daily, beginning on Day 1 of her menstrual cycle. (The
first day of menstruation is Day 1.) She should take one pink Beyaz daily for
24 consecutive days, followed by one light orange tablet daily on Days 25
through 28. Beyaz should be taken in the order directed on the package at the
same time each day, preferably after the evening meal or at bedtime with some
liquid, as needed. Beyaz can be taken without regard to meals. If Beyaz is
first taken later than the first day of the menstrual cycle, Beyaz should not
be considered effective as a contraceptive until after the first 7 consecutive
days of product administration. Instruct the patient to use a non-hormonal
contraceptive as back-up during the first 7 days. The possibility of ovulation
and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of Beyaz use, instruct the patient to
take one pink Beyaz daily, beginning on the first Sunday after the onset of her
menstrual period. She should take one pink Beyaz daily for 24 consecutive days,
followed by one light orange tablet daily on Days 25 through 28. Beyaz should
be taken in the order directed on the package at the same time each day,
preferably after the evening meal or at bedtime with some liquid, as needed.
Beyaz can be taken without regard to meals. Beyaz should not be considered
effective as a contraceptive until after the first 7 consecutive days of
product administration. Instruct the patient to use a non-hormonal
contraceptive as back-up during the first 7 days. The possibility of ovulation
and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day
regimens of Beyaz on the same day of the week that she began her first regimen,
following the same schedule. She should begin taking her pink tablets on the
next day after ingestion of the last light orange folate tablet, regardless of
whether or not a menstrual period has occurred or is still in progress. Anytime
a subsequent cycle of Beyaz is started later than the day following
administration of the last light orange tablet, the patient should use another
method of contraception until she has taken a pink Beyaz daily for seven
consecutive days.

When switching from a different birth control pill

When switching from another birth control pill, Beyaz should
be started on the same day that a new pack of the previous oral contraceptive
would have been started.

When switching from a method other than a birth control pill

When switching from a transdermal patch or vaginal ring,
Beyaz should be started when the next application would have been due. When
switching from an injection, Beyaz should be started when the next dose would
have been due. When switching from an intrauterine contraceptive or an implant,
Beyaz should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following
the last pink tablet. If spotting or breakthrough bleeding occurs while taking
Beyaz, instruct the patient to continue taking Beyaz by the regimen described
above. Counsel her that this type of bleeding is usually transient and without
significance; however, advise her that if the bleeding is persistent or
prolonged, she should consult her healthcare provider.

Although the occurrence of pregnancy is low if Beyaz is taken
according to directions, if withdrawal bleeding does not occur, consider the
possibility of pregnancy. If the patient has not adhered to the prescribed
dosing schedule (missed one or more active tablets or started taking them on a
day later than she should have), consider the possibility of pregnancy at the
time of the first missed period and take appropriate diagnostic measures. If
the patient has adhered to the prescribed regimen and misses two consecutive
periods, rule out pregnancy. Discontinue Beyaz if pregnancy is confirmed.

The risk of pregnancy increases with each active pink tablet
missed. For additional patient instructions regarding missed pills, see the “WHAT
TO DO IF YOU MISS PILLS” section in the FDA Approved Patient
Labeling. If breakthrough bleeding occurs following missed tablets,
it will usually be transient and of no consequence. If the patient misses one
or more light orange tablets, she should still be protected against pregnancy
provided she begins taking a new cycle of pink tablets on the proper day.

For postpartum women who do not breastfeed or after a second
trimester abortion, start Beyaz no earlier than 4 weeks postpartum due to the
increased risk of thromboembolism. If the patient starts on Beyaz postpartum
and has not yet had a period, evaluate for possible pregnancy, and instruct her
to use an additional method of contraception until she has taken Beyaz for 7
consecutive days.

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not
be complete and additional contraceptive measures should be taken. If vomiting
occurs within 3-4 hours after tablet-taking, this can be regarded as a missed
tablet.

Folate Supplementation

The U.S. Preventive Services Task Force recommends that women
of childbearing age consume supplemental folic acid in a dose of at least 0.4
mg (400 mcg) daily.1 Consider other folate supplementation that a
woman may be taking before prescribing Beyaz. Ensure that folate
supplementation is maintained if a woman discontinues Beyaz due to pregnancy.